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NCT Number: NCT07749989

A Retrospective Analysis of Patients With Gastroesophageal Reflux Disease Based on a Prospective Clinical Dataset

This retrospective, observational cohort study aimed to establish a comprehensive research cohort utilizing a large-scale prospective clinical registry. The primary objectives were to characterize the real-world demographic profiles, clinical features, psychological characteristics, and treatment patterns of Chinese patients with gastroesophageal reflux disease (GERD), as well as to evaluate post-treatment improvements in both GERD symptoms and psychological well-being. The study retrospectively enrolled approximately 5,000 patients with a confirmed diagnosis of GERD, with data derived from the prospective registry of the National Clinical Research Center for Digestive Diseases. Investigators systematically extracted data on baseline demographics, clinical presentations, objective diagnostic findings, preoperative psychological status, surgical complications, and longitudinal follow-up outcomes for all eligible patients. Ultimately, this study sought to provide high-quality, China-specific evidence to inform the precise phenotyping of GERD and to guide standardized, individualized clinical decision-making.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

Location status: Recruiting

Location contact

Zhi Zheng, Attending surgon

CONTACT

[email protected]

+86-13811132175

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged between 18 and 90 years old.
  • Patients were required to present with at least one typical symptom of gastroesophageal reflux disease (GERD)-such as heartburn, regurgitation, or non-cardiac chest pain-and to have presented to Beijing Friendship Hospital for the evaluation and management of these symptoms.
  • Received treatment, including pharmacological therapy and anti-reflux surgery, at Beijing Friendship Hospital.
  • Voluntary signing of informed consent, agreeing to the use of clinical information for future research.

Exclusion criteria

  • Female patients who were pregnant or lactating.
  • Patients with significantly incomplete or missing critical clinical data.
  • Patients with an equivocal or unconfirmed diagnosis of GERD.
  • Current neurologic or cognitive impairment, which would preclude ability to obtain informed consent.
  • Refusal to participate in the study.

Treatment and study plan

Clinical data collection

Other

Data on clinical symptoms, treatment details, and long-term follow-up outcomes were retrospectively extracted from electronic medical records (EMRs) and institutional databases.

Primary outcomes

  1. Pre- and Post-Treatment Improvement in GERD-HRQL Scores

    Time frame: From pre-treatment to up to 10 years post-treatment

    The Gastroesophageal Reflux Disease Health-Related Quality of Life (GERD-HRQL) questionnaire is utilized to assess patient outcomes as a quantitative variable. The scale comprises 11 items, each scored from 0 to 5, with higher scores indicating a better quality of life (QoL). Clinical success is defined as a >50% reduction in the total symptom score.

Secondary outcomes

  1. Pre- and Post-Treatment Improvement in GERD-Q Scores

    Time frame: From pre-treatment to up to 10 years post-treatment

    The Gastroesophageal Reflux Disease Questionnaire (GERD-Q) is utilized to evaluate GERD symptoms. The total score ranges from 0 to 18, with higher scores indicating greater symptom severity.

  2. Pre- and Post-Treatment Improvement in GSAS Scores

    Time frame: From pre-treatment to up to 10 years post-treatment

    The GERD Symptom Assessment Scale (GSAS) is employed to evaluate GERD symptoms. The total score ranges from 0 to 45, with higher scores indicating greater symptom severity.

  3. Pre- and Post-Treatment Improvement in GIQLI Scores

    Time frame: From pre-treatment to up to 10 years post-treatment

    The Gastrointestinal Quality of Life Index (GIQLI) is utilized to assess quality of life in patients with gastrointestinal diseases. It comprises five subscales with a total score ranging from 0 to 144. Higher scores indicate a better quality of life and superior therapeutic efficacy.

  4. Pre- and Post-Treatment Improvement in EHAS Scores

    Time frame: From pre-treatment to up to 10 years post-treatment

    The Esophageal Hypervigilance and Anxiety Scale (EHAS) is utilized to assess esophageal-specific hypervigilance and anxiety. It comprises two subscales with a total score ranging from 0 to 56, with higher scores indicating more severe esophageal hypervigilance and anxiety.

  5. Pre- and Post-Treatment Improvement in HADS Scores

    Time frame: From pre-treatment to up to 10 years post-treatment

    The Hospital Anxiety and Depression Scale (HADS) is employed to evaluate patient anxiety and depression. It comprises two subscales with a total score ranging from 0 to 42, with higher scores indicating more severe states of anxiety and depression.

  6. Esophagitis Severity

    Time frame: From pre-treatment to up to 10 years post-treatment

    Evaluated via gastroscopy according to the Los Angeles (LA) classification.

  7. Severity of Hiatal Hernia

    Time frame: From pre-treatment to up to 10 years post-treatment

    Evaluated via gastroscopy according to the Hill classification.

  8. Presence of Barrett's Esophagus

    Time frame: From pre-treatment to up to 10 years post-treatment

    Evaluated via gastroscopy.

  9. Acid Exposure Time (AET)

    Time frame: From pre-treatment to up to 10 years post-treatment

    Quantified via pH-impedance monitoring. AET serves as the primary and most reliable metric for diagnosing objective GERD and evaluating the true burden of acid reflux, >4% indicate abnormal acid reflux

  10. Number of Reflux Episodes

    Time frame: From pre-treatment to up to 10 years post-treatment

    Quantified via pH-impedance monitoring.

  11. DeMeester Score

    Time frame: From pre-treatment to up to 10 years post-treatment

    The DeMeester Composite Score quantifies the severity of Gastroesophageal Reflux Disease (GERD). It is calculated from 24-hour ambulatory esophageal pH monitoring using six acid exposure parameters: percentage of total, upright, and supine time with pH < 4; total reflux episodes; episodes lasting > 5 minutes; and the duration of the longest episode. Each parameter is scored using the formula SV = (X - A) / SD + 1, where X is the measured value, A is the healthy baseline mean, and SD is the baseline standard deviation. The total score is the sum of these six values. Minimum value: 0. Maximum value: No fixed upper limit (unbounded). In clinical applications, higher scores indicate more severe pathological acid exposure.

  12. Symptom Index (SI)

    Time frame: From pre-treatment to up to 10 years post-treatment

    Derived from pH-impedance monitoring to determine the temporal correlation between symptom events and reflux episodes, confirming whether a patient's symptoms are specifically reflux-driven. An SI of ≥ 50% is universally considered positive, indicating a clinically meaningful symptom-reflux association.

  13. Symptom Reflux Index (SRI)

    Time frame: From pre-treatment to up to 10 years post-treatment

    Derived from pH-impedance monitoring to provide statistical validation of the symptom-reflux association, which is crucial for accurately phenotyping functional versus organic GERD. An SRI of ≥ 95% (often utilized interchangeably with Symptom Association Probability, SAP) is considered positive, providing strong statistical evidence that symptoms are not occurring by chance.

  14. Esophagogastric Junction (EGJ) Expiratory Pressure

    Time frame: From pre-treatment to up to 10 years post-treatment

    Measured via high-resolution manometry (HRM).

  15. Integrated Relaxation Pressure (IRP)

    Time frame: From pre-treatment to up to 10 years post-treatment

    Measured via high-resolution manometry (HRM).

  16. Esophagogastric Junction (EGJ) Morphology

    Time frame: From pre-treatment to up to 10 years post-treatment

    Evaluated via high-resolution manometry (HRM) to assess hiatal hernia status.

  17. Distal Latency (DL)

    Time frame: From pre-treatment to up to 10 years post-treatment

    Measured via high-resolution manometry (HRM).

  18. Distal Contractile Integral (DCI)

    Time frame: From pre-treatment to up to 10 years post-treatment

    Measured via high-resolution manometry (HRM).

  19. Esophageal Motility Type

    Time frame: From pre-treatment to up to 10 years post-treatment

    Evaluated via high-resolution manometry (HRM) according to the Chicago classification.

  20. Hiatal Hernia Size

    Time frame: From pre-treatment to up to 10 years post-treatment

    Evaluated via computed tomography (CT).

  21. Helicobacter pylori Infection Status

    Time frame: From 30 days prior to surgery to 10 years post-surgery

    Helicobacter pylori infection status determined by ¹³C/¹⁴C urea breath test.

  22. Acid-Suppressive Medication Regimen

    Time frame: From enrollment to the end of treatment, assessed up to 12 weeks

    This encompasses the specific medication name, prescribed dosage, and administration frequency.

  23. Operation Time

    Time frame: At the time of surgery

  24. Blood Loss

    Time frame: At the time of surgery

  25. Abdominal Drainage Fluid Volume

    Time frame: From treatment to 30 days after surgery

  26. Total Duration of Hospitalization

    Time frame: From treatment to 30 days after surgery

  27. Incidence of Postoperative Complications

    Time frame: From treatment to 30 days after surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Zhi Zheng, Attending surgon

CONTACT

[email protected]

+86-13811132175

Sponsors and collaborators

Lead sponsor

Beijing Friendship Hospital

Other

Registry information

Official study title

Establishing an Innovative Cohort of Chinese Patients With Gastroesophageal Reflux Disease Based on the Prospective Database of the National Clinical Research Center for Digestive Diseases: A Retrospective Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 6, 2026
Registry last updated
Aug 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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